(NYSE MKT: CVM)
announced today that following an audit of its Multikine
manufacturing plant and laboratories by a European Union (EU) Qualified Person (QP), the CEL-SCI facilities were found to be in a high level of compliance with the Good Manufacturing Practices (GMP) Directives of the EU and the International Conference on Harmonization (ICH). This inspection follows a successful inspection by a different QP in late 2010.
The EU, unlike other countries included in CEL-SCI’s ongoing Phase III trial, requires every lot or batch of medicinal product intended for use in a clinical trial that is being conducted within its member states to be released by a QP to ensure the product’s safety and compliance with the EU Directives. Each QP must be certified individually by the EU regulatory body to become a QP and needs to have extensive training and an in-depth critical understanding of all the aspects associated with manufacturing and distribution of drug products. Penn Pharmaceutical Services Ltd, UK, which has conducted this QP Audit, is providing QP service to CEL-SCI for the clinical Lot certification, and is engaged in releasing the clinical lots of the investigational drug Multikine for use in the EU. The most recent audit concluded that CEL-SCI appears a well-managed organization with a clear commitment to the quality of its product, having well qualified and trained staff, and that both the manufacturing and laboratory facilities are of high caliber and more than adequate for their intended purpose.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.